,,ii #aafth ,,congress #ast ,session ,s4 #hdd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ad1 #bjai,ms4 ,klobuchar 7for herself1 ,mr4 ,lee1 ,mr4 ,durbin1 and ,mr4 ,grassley7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages4 #a4 ,short title ,this ,act may be cited as the ,short on ,competition ,act4 #b4 ,temporary importation of prescription drugs 7a7 ,temporary importation ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 by redesignating subsections 7h7 and 7i7 as subsections 7i7 and 7j71 respectively2 and 7#b7 by inserting after subsection 7g7 the following3 7h7 ,temporary importation authority 7#a7 ,in general ,if1 based on notifications described in subsection 7a7 or any other relevant information1 the ,secretary concludes that there is1 or is likely to be1 a drug shortage of a drug described in subsection 7a71 except as provided in paragraph 7#c71 the ,secretary shall authorize importation of such drug for a period of up to #c years if-- 7,a7 the drug is a drug subject to section #ejc7;b77#a71 including a combination product whose primary mode of action is that of a drug as determined under section #ejc7;g77#a77;,d77i71 other than a drug described in subparagraphs 7,a7 through 7,f7 of section #hjd7;a77#c72 7,b7 the drug is authorized to be lawfully marketed in one or more of the countries included in the list under section #hjb7;b77#a72 7,c7 the imported drug has the same active ingredient as the drug for which there is a shortage with respect to manufacturers in the ,united ,states2 7,d7 the manufacturer certifies to the ,secretary that it intends to seek approval of the drug under section #eje7;j72 and 7,e7 an importer 7as defined in section #hjd7;a77 files with the ,secretary information-- 7i7 attesting that the requirements under subparagraphs 7,a7 through 7,d7 are satisfied2 7ii7 identifying the drug the importer proposes to import and the manufacturer from whom the importer proposes to import such drug2 and 7iii7 requesting authority to import the drug4 7#b7 ,beginning date of importation ,except as provided in paragraph 7#c71 if all of the conditions under paragraph 7#a7 are met1 the ,secretary shall authorize importation of a drug in accordance with such paragraph beginning not later than #fj days after receipt of the information under paragraph 7#a77;,e74 7#c7 ,discretionary denial of importation ,the ,secretary may deny importation of a drug otherwise qualified for importation under paragraph 7#a7 if the ,secretary determines that-- 7,a7 the drug is not safe and effective2 7,b7 the drug is used in conjunction with a device for which there is no reasonable assurance of safety and effectiveness2 or 7,c7 the authorization to market the drug in one or more of the countries included in the list under section #hjb7;b77#a7 has been rescinded or withdrawn because of any concern relating to the safety or effectiveness of the drug4 7#d7 ,termination of authority ,the authority to import a drug pursuant to paragraph 7#a7 shall terminate after #c years1 or when the drug shortage no longer applies1 whichever occurs first4 4 7b7 ,marginally competitive drug markets ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,c-#a the following3 #ejf;,c-#b4 ,marginally competitive drug markets 7a7 ,in general ,if the ,secretary determines under subsection 7b7 that a marginally competitive market exists with respect to an applicable drug1 the ,secretary-- 7#a7 shall treat such marginally competitive market as creating a drug shortage only for purposes of subsections 7g7 and 7h7 of section #ejf;,c2 and 7#b7 7,a7 may expedite the review of applications and inspections with respect to the drug in accordance with section #ejf;,c7g72 and 7,b7 shall authorize importation of the drug in accordance with section #ejf;,c7h74 7b7 ,determination of marginally competitive market 7#a7 ,in general ,the ,secretary shall determine that a marginally competitive market exists with respect to an applicable drug if-- 7,a7 for at least #b consecutive months prior to the determination1 fewer than #e drugs approved under section #eje7;c7 7referred to in this paragraph as the #8applicable listed drug'7 or under section #eje7;j7 that reference the applicable listed drug were commercially available in the ,united ,states2 7,b7 the applicable listed drug was approved at least #aj years before such determination2 and 7,c7 each patent which claims an active ingredient of the applicable listed drug has expired4 7#b7 ,commercially available 7,a7 ,in general ,for purposes of paragraph 7#a77;,a71 a drug is not commercially available in the ,united ,states if-- 7i7 the holder of an application approved under subsection 7c7 or 7j7 of section #eje has publicly announced that it has discontinued the manufacturing of the drug2 7ii7 a drug approved under subsection 7c7 or 7j7 of section #eje has been withdrawn or discontinued2 or 7iii7 the ,secretary has any other reasonable basis to conclude that a drug approved under subsection 7c7 or 7j7 of section #eje is not competitively relevant4 7,b7 ,holder of approved application ,in determining whether #e drugs are commercially available under paragraph 7#a77;,a71 in the case of a single person who is the holder of more than one application approved as described in paragraph 7#a77;,a7 with respect to an applicable drug1 only one such drug shall be considered to be commercially available4 7c7 ,applicable drug ,in this section1 the term applicable drug means a drug that is not a radio pharmaceutical drug product or any other product as designated by the ,secretary4 4 7c7 ,annual reporting on drug shortages ,section #ejf;,c-#a7;a77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77#c77;,b77 is amended-- 7#a7 in clause 7i71 by striking 2 and and inserting 22 7#b7 in clause 7ii71 by adding and after the semicolon2 and 7#c7 by inserting after clause 7ii7 the following3 7iii7 the number of drugs authorized for temporary importation under section #ejf;,c7h72 4